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Challenges in evaluating cancer as a clinical outcome in postapproval studies of drug safety.
Pinheiro, Simone P; Rivera, Donna R; Graham, David J; Freedman, Andrew N; Major, Jacqueline M; Penberthy, Lynne; Levenson, Mark; Bradley, Marie C; Wong, Hui-Lee; Ouellet-Hellstrom, Rita.
Afiliação
  • Pinheiro SP; Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD. Electronic address: simone.pinheiro@fda.hhs.gov.
  • Rivera DR; Clinical & Translational Epidemiology Branch, Epidemiology and Genomics Research, Division of Cancer Control and Population Sciences, National Cancer Institute, Rockville, MD.
  • Graham DJ; Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD.
  • Freedman AN; Clinical & Translational Epidemiology Branch, Epidemiology and Genomics Research, Division of Cancer Control and Population Sciences, National Cancer Institute, Rockville, MD.
  • Major JM; Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD.
  • Penberthy L; Clinical & Translational Epidemiology Branch, Epidemiology and Genomics Research, Division of Cancer Control and Population Sciences, National Cancer Institute, Rockville, MD.
  • Levenson M; Office of Biostatistics, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD.
  • Bradley MC; Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD; Clinical & Translational Epidemiology Branch, Epidemiology and Genomics Research, Division of Cancer Control and Population Sciences, National Cancer Institute, R
  • Wong HL; Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD.
  • Ouellet-Hellstrom R; Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD.
Ann Epidemiol ; 26(11): 735-740, 2016 11.
Article em En | MEDLINE | ID: mdl-27663208
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Texto completo: 1 Base de dados: MEDLINE Assunto principal: Vigilância de Produtos Comercializados / United States Food and Drug Administration / Resultado do Tratamento / National Cancer Institute (U.S.) / Neoplasias / Antineoplásicos Idioma: En Ano de publicação: 2016 Tipo de documento: Article
Texto completo
Imprimir
XML
PubMed Links
Buscar no Google

Texto completo: 1 Base de dados: MEDLINE Assunto principal: Vigilância de Produtos Comercializados / United States Food and Drug Administration / Resultado do Tratamento / National Cancer Institute (U.S.) / Neoplasias / Antineoplásicos Idioma: En Ano de publicação: 2016 Tipo de documento: Article